在开发工艺过程分析技术(PAT)的使用上所作的承诺和投入是制药工业能够找到系统化和改进生产工艺过程的主要原因。然而，在实施工艺过程分析技术(PAT)时存在各种明显的挑战，比如像测量仪器与分级危害性区域以及现有工艺加工基础设施的匹配性。更重要的是，怎样做到原位化学采样分析。现今在运行使用的大部分反应器容器都缺乏适合这类测量技术所需的进入点，为此要作修改或取代，这会显著增加项目成本或彻底阻止实施。 Continue reading
Commitment and investment to develop the use of Process Analytical Technology (PAT) is a primary reason why the pharmaceutical industry is able to find ways to streamline and improve manufacturing processes. However, there are significant challenges when implementing Process Analytical Technology (PAT) into larger-scale manufacturing, such as compatibility of measurement instrumentation with classified hazardous areas and the existing processing infrastructure. Even more important is how to sample the chemistry in situ. The majority of reactor vessels in commission today lack suitable entry points for the measurement technology that requires there modification or replacement, which can significantly increase project costs or prohibit implementation entirely. Continue reading
Ian Clegg, an Associate Research Fellow at Pfizer Global Research and Development Sandwich Laboratories, United Kingdom recently posted a discussion on LinkedIn’s Process Analytical Technology (PAT) group site titled “PAT data (Mid-IR) posted onto YouTube.”
This YouTube video is entitled “Process Analytical Technology: Using Mid-IR spectroscopy to monitor a telescoped chemical reaction.”
In this video, 3 sequential chemical reactions are run in one vessel without stopping or isolating between reactions, and ReactIR™ (real-time in situ reaction analysis) is used to monitor all 3 reaction phases. All of the key reagents, intermediates and products produce unique peaks which show reaction progression without having to take samples. The video shows the spectra of the reaction as a function of time and how the spectra change. The video shows clearly which peaks were monitored and to which components those peaks correlate.